Catalog Number

-

Brand Name

N/A

Version/Model Number

DU1025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092627,K092627

Product Code

IMG

Product Code Name

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Public Device Record Key

d1e1a309-732e-47cd-ba9b-52568ce87ffc

Public Version Date

April 08, 2019

Public Version Number

4

DI Record Publish Date

October 13, 2016

Package DI Number

80092237616808

Quantity per Package

20

Contains DI Package

00092237616802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA